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Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis.
N Engl J Med. 2010 Jan 14; 362(2):118-28.NEJM

Abstract

BACKGROUND

Biologic agents offer a range of new therapeutic options for patients with psoriasis; however, the relative benefit-risk profiles of such therapies are not well known. We compared two biologic agents, ustekinumab (an interleukin-12 and interleukin-23 blocker) and etanercept (an inhibitor of tumor necrosis factor alpha), for the treatment of psoriasis.

METHODS

We randomly assigned 903 patients with moderate-to-severe psoriasis to receive subcutaneous injections of either 45 or 90 mg of ustekinumab (at weeks 0 and 4) or high-dose etanercept (50 mg twice weekly for 12 weeks). The primary end point was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI) at week 12; a secondary end point was the proportion with cleared or minimal disease on the basis of the physician's global assessment. Assessors were unaware of the treatment assignments. The efficacy and safety of a crossover from etanercept to ustekinumab were evaluated after week 12.

RESULTS

There was at least 75% improvement in the PASI at week 12 in 67.5% of patients who received 45 mg of ustekinumab and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received etanercept (P=0.01 and P<0.001, respectively). Similarly, 65.1% of patients who received 45 mg of ustekinumab and 70.6% of patients who received 90 mg of ustekinumab had cleared or minimal disease according to the physician's global assessment, as compared with 49.0% of those who received etanercept (P<0.001 for both comparisons). Among patients who did not have a response to etanercept, 48.9% had at least 75% improvement in the PASI within 12 weeks after crossover to ustekinumab. One or more adverse events occurred through week 12 in 66.0% of patients who received 45 mg of ustekinumab and 69.2% of patients who received 90 mg of ustekinumab and in 70.0% who received etanercept; 1.9%, 1.2%, and 1.2%, respectively, had serious adverse events. Safety patterns were similar before and after crossover from etanercept to ustekinumab.

CONCLUSIONS

The efficacy of ustekinumab at a dose of 45 or 90 mg was superior to that of high-dose etanercept over a 12-week period in patients with psoriasis. (ClinicalTrials.gov number, NCT00454584.)

Links

Aggregator Full Text
Publisher Full Text
nejm.org
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Authors+Show Affiliations

Griffiths CE
University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom. christopher.griffiths@manchester.ac.uk
Strober BE
No affiliation info available
van de Kerkhof P
No affiliation info available
Ho V
No affiliation info available
Fidelus-Gort R
No affiliation info available
Yeilding N
No affiliation info available
Guzzo C
No affiliation info available
Xia Y
No affiliation info available
Zhou B
No affiliation info available
Li S
No affiliation info available
Dooley LT
No affiliation info available
Goldstein NH
No affiliation info available
Menter A
No affiliation info available
ACCEPT Study Group
No affiliation info available

MeSH

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedEtanerceptFemaleHumansImmunoglobulin GImmunologic FactorsImmunosuppressive AgentsInterleukin-12Interleukin-23MaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorSeverity of Illness IndexTumor Necrosis Factor-alphaUstekinumab

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20071701

Clinical Trial Links

Clinical trial which this article describes
Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP)
Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.

Citation

Griffiths, Christopher E M., et al. "Comparison of Ustekinumab and Etanercept for Moderate-to-severe Psoriasis." The New England Journal of Medicine, vol. 362, no. 2, 2010, pp. 118-28.
Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010;362(2):118-28.
Griffiths, C. E., Strober, B. E., van de Kerkhof, P., Ho, V., Fidelus-Gort, R., Yeilding, N., Guzzo, C., Xia, Y., Zhou, B., Li, S., Dooley, L. T., Goldstein, N. H., & Menter, A. (2010). Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. The New England Journal of Medicine, 362(2), 118-28. https://doi.org/10.1056/NEJMoa0810652
Griffiths CE, et al. Comparison of Ustekinumab and Etanercept for Moderate-to-severe Psoriasis. N Engl J Med. 2010 Jan 14;362(2):118-28. PubMed PMID: 20071701.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. AU - Griffiths,Christopher E M, AU - Strober,Bruce E, AU - van de Kerkhof,Peter, AU - Ho,Vincent, AU - Fidelus-Gort,Roseanne, AU - Yeilding,Newman, AU - Guzzo,Cynthia, AU - Xia,Yichuan, AU - Zhou,Bei, AU - Li,Shu, AU - Dooley,Lisa T, AU - Goldstein,Neil H, AU - Menter,Alan, AU - ,, PY - 2010/1/15/entrez PY - 2010/1/15/pubmed PY - 2010/1/26/medline SP - 118 EP - 28 JF - The New England journal of medicine JO - N Engl J Med VL - 362 IS - 2 N2 - BACKGROUND: Biologic agents offer a range of new therapeutic options for patients with psoriasis; however, the relative benefit-risk profiles of such therapies are not well known. We compared two biologic agents, ustekinumab (an interleukin-12 and interleukin-23 blocker) and etanercept (an inhibitor of tumor necrosis factor alpha), for the treatment of psoriasis. METHODS: We randomly assigned 903 patients with moderate-to-severe psoriasis to receive subcutaneous injections of either 45 or 90 mg of ustekinumab (at weeks 0 and 4) or high-dose etanercept (50 mg twice weekly for 12 weeks). The primary end point was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI) at week 12; a secondary end point was the proportion with cleared or minimal disease on the basis of the physician's global assessment. Assessors were unaware of the treatment assignments. The efficacy and safety of a crossover from etanercept to ustekinumab were evaluated after week 12. RESULTS: There was at least 75% improvement in the PASI at week 12 in 67.5% of patients who received 45 mg of ustekinumab and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received etanercept (P=0.01 and P<0.001, respectively). Similarly, 65.1% of patients who received 45 mg of ustekinumab and 70.6% of patients who received 90 mg of ustekinumab had cleared or minimal disease according to the physician's global assessment, as compared with 49.0% of those who received etanercept (P<0.001 for both comparisons). Among patients who did not have a response to etanercept, 48.9% had at least 75% improvement in the PASI within 12 weeks after crossover to ustekinumab. One or more adverse events occurred through week 12 in 66.0% of patients who received 45 mg of ustekinumab and 69.2% of patients who received 90 mg of ustekinumab and in 70.0% who received etanercept; 1.9%, 1.2%, and 1.2%, respectively, had serious adverse events. Safety patterns were similar before and after crossover from etanercept to ustekinumab. CONCLUSIONS: The efficacy of ustekinumab at a dose of 45 or 90 mg was superior to that of high-dose etanercept over a 12-week period in patients with psoriasis. (ClinicalTrials.gov number, NCT00454584.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/20071701/Comparison_of_ustekinumab_and_etanercept_for_moderate_to_severe_psoriasis_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa0810652?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -